NattoPharma has entered into pharmaceutical market by allowing its natural vitamin K2, MenaQ7, to be used in the VitaVasK study, a placebo-controlled, double-blind multinational European randomized trial.
The VitaVasK study will last for three years and will measure placebo controlled effect of high doses of MenaQ7 in some 600 kidney patients over one and a half years. The study is being financed by a EUR1.8m grant from the European Renal Association.
The hypothesis that the dietary supplementation of MenaQ7 can delay the progression of vascular and valvular calcification in patients on chronic hemodialysis will be tested.
The studies carried out at MaastrichtUniversity, in collaboration with NattoPharma, indicate that MenaQ7 has the potential to prevent or even reduce vascular calcification. Especially in patients prone to vascular calcification, such as those with chronic kidney disease, this calcification reduction may positively influence patient outcome.
In a pilot study, it was shown that hemodialysis patients revealed an extreme vitamin K deficiency and inactive Matrix Gla protein (MGP), indicating that they do not have the ability to protect against arterial calcification. It was shown that six weeks of MenaQ7 supplementation increased the active MGP levels in these patients in a dose-dependent manner, suggesting that disturbed calcification inhibitory activity in the vasculature may be improved by MenaQ7 supplementation, expecting a better outcome for dialysis patients.
Leon Schurgers, senior scientist at MaastrichtUniversity and VP of R&D at NattoPharma, said, "The accumulation of calcium salts in the arteries results in stiffening and increased fragility. This might be considered a 'silent killer' as hardening of the arteries develops without any symptoms over time. The process of calcification is an actively regulated process and that adequate MenaQ7 intake can prevent this process and eliminate this risk factor."
Morten Sundsto, CEO of NattoPharma, said, "We see this as our first step into the pharmaceutical market. Until now, we have only done trials in healthy subjects. Now, for the first time, we are part of a large trial in dialysis patients suffering from a disease with a high mortality. Thus, if this trial is successful, we see a great potential for MenaQ7 as a drug in the future."